NCT00000306

Brief Summary

The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 1994

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1994

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related DisordersOpioid-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (7)

  • Craving

  • Drug use

  • Medication compliance

  • Retention

  • Addiction severity

  • Mood indicators

  • Psychiatric interview

Secondary Outcomes (1)

  • Effectiveness measures including psycho-social variables, side effects, and self-reported measures.

Interventions

DextroamphetamineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID.
  • Be between 18 and 45 years old
  • Women must agree to use contraception
  • Have an EKG that has been confirmed by a cardiologist
  • Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal

You may not qualify if:

  • Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent
  • Have any Axis I disorder that is not related to drug use
  • Have current dependence on any psychoactive disorder other than nicotine
  • Be on probation or parole for reasons other than those related to drug charges (ASI)
  • Be pregnant or lactating
  • Have been in any outside treatment in 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77225, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersOpioid-Related Disorders

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Intervention Hierarchy (Ancestors)

AmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • John Grabowski, Ph.D.

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

September 1, 1994

Study Completion

September 1, 2001

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)